Clinical Trial: Effect of Buccal Fat Pad Derived Stem Cells in Maxillary Sinus Augmentation

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Effect of Buccal Fat Pad Derived Mesenchymal Stem Cells Loaded on Allograft and Platelet-rich Plasma in Maxillary Sinus Augmentation

Brief Summary: In this study the buccal fat pad derived stem cells (BFPSCs) will be harvested from buccal fat pad tissue of patients receiving maxillary sinus augmentation. In the test group the patients receive a combination of platelet rich fibrin (PRF) and freeze dried bone allograft (FDBA) (SureOss, Hansbiomed, Korea) loaded with BFPSCs. The results will be evaluated by cone beam computed tomography (CBCT)and hematoxylin and eosin staining in 6 months.

Detailed Summary:

The buccal fat pad derived stem cells (BFPSCs) is harvested from buccal fat pad tissues. The BFPSCs will be loaded on freeze dried bone allograft (FDBA) (SureOss, Hansbiomed, Korea). Furthermore, twenty milliliters of the venous blood is obtained, placed and collected in a sterile tube, and centrifuged (GAC medical) for 14 minutes at 2800 rpm (approximately 400 g). Following centrifugation, three layers are separated in the tube: cellular plasma at the top, platelet rich fibrin (PRF) clot in the middle and red blood cells at the bottom of the tube. The PRF clot is separated by a sterile pincette.

The patients in the test group receives BFPSCs loaded on DFDBA with PRF for sinus augmentation and the control group receives combination of PRF and DFDBA (lacking any cells).The results will be evaluated by cone beam computed tomography (CBCT) in 6 months and microscopic evaluation of the biopsies by hematoxylin and eosine staining.


Sponsor: Shahid Beheshti University of Medical Sciences

Current Primary Outcome:

  • amount of regenerated bone [ Time Frame: 6 months ]
    the amount of regenerated bone will be assessed by Image Pro software in CBCT images
  • amount of regenerated bone [ Time Frame: 6 months ]
    the percent of regenerated bone will be assessed on bone biopsies obtained during implant insertion by H&E staining by microscope


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Shahid Beheshti University of Medical Sciences

Dates:
Date Received: April 18, 2016
Date Started: January 2016
Date Completion: December 2016
Last Updated: October 13, 2016
Last Verified: October 2016